FDA has announced an immediate partial stop work order to state contracted entities for activities such as compliance checks and vape shop inspections in light of the COVID-19 outbreak and in keeping with the White House Coronavirus Task Force and cross-government guidance.
While this stoppage does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, FDA has indicated it will continue to adjust its approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco.
According to Mitch Zeller, CTP Director at FDA, while inspections will cease immediately, administrative work can continue for two weeks, and the entire situation will be reevaluated over the coming four weeks.
Though inspections are being temporarily halted, it goes without saying that all FDA regulated industries must remain vigilant in ensuring compliance requirements continue to be met. Now is not the time to lose our focus on the safety and legality of our products.
If EAS can be of assistance with any questions related to your current compliance status or how to strengthen operations to better meet FDA expectations, please do not hesitate to contact me.
Thanks and take care,
Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com
Posted in COVID-19, Dietary Supplements, Drugs, Foods, Medical Devices, Tobacco.